Search Results: CFR:21 CFR Part 522

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1. Implantation or Injectable Dosage Form New Animal Drugs; Change of Sponsor

RULES: Sponsor name and address changes—; Ivy Laboratories,

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for an approved new animal drug application (NADA) from Elanco Animal Health, A Division of Eli Lilly & Co., to Ivy Laboratories, Div. of Ivy Animal Health, Inc.
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

2. Implantation or Injectable Dosage Form New Animal Drugs; Change of Sponsor

RULES: Sponsor name and address changes—; Phoenix Scientific, Inc.,

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for two approved new animal drug applications (NADA's) from Pfizer, Inc., to Phoenix Scientific, Inc.
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

3. Implantation or Injectable Dosage Form New Animal Drugs; Moxidectin

RULES: Moxidectin,

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Fort Dodge Animal Health. The NADA provides for veterinary prescription use of a sustainedrelease injectable moxidectin formulation for prevention of heartworm disease and treatment of
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

4. Implantation or Injectable Dosage Form New Animal Drugs; Ceftiofur Sterile Powder for Injection

RULES: Ceftiofur sterile powder for injection in cattle,

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pharmacia and Upjohn Co. The supplemental NADA provides for subcutaneous injection of a solution of reconstituted ceftiofur sodium powder in cattle.
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

5. Implantation or Injectable Dosage Form New Animal Drugs; Ivermectin

RULES: Ivermectin injection,

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Phoenix Scientific, Inc. The ANADA provides for use of ivermectin injection for the treatment and control of various species of external and internal parasites in cattle,
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

6. Implantation or Injectable Dosage Form New Animal Drugs; Oxytetracycline Injection

RULES: Oxytetracycline injection,

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Pennfield Oil Co. The ANADA provides for the subcutaneous administration of oxytetracycline injectable solution in cattle.
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

7. Implantation or Injectable Dosage Form New Animal Drugs; Ceftiofur Sterile Powder for Injection

RULES: Ceftiofur sterile powder for injection,

AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pharmacia and Upjohn Co. The supplemental NADA provides for intramuscular
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
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